510(k) K853841
K853841 is an FDA 510(k) premarket notification submitted by U.S. Shizai Corp. for the device "HARMO SONIC". The FDA issued a decision of Substantially Equivalent on February 4, 1986. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. U.S. Shizai Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 1986
- Date Received
- September 16, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type